Clinical Trial Manager in Oncology [f/m/d]

Thermosome is an entrepreneurial biopharmaceutical company located in Martinsried near Munich that strives to develop proprietary drug candidates in the field of oncology. Core of our development is our unique, proprietary and patent-protected drug delivery technology using a thermo-sensitive nanocarrier for local high-concentrated delivery of active pharmaceutical ingredients (APIs). Our nanocarrier encapsulates APIs safely at normal body temperature, but instantly releases the APIs once entering mildly heated tissue (achieved through approved medical devices). Our lead drug candidate has shown pre-clinical proof-of-concept in several species, has performed formal toxicological testing and shall be moved into clinical development in the future.

To support our clinical operations team and plan our sponsor-financed Phase I study, we are looking for a
 
Clinical Trial Manager [f/m/d]

Activities and responsibilities

  • Management of clinical trial activities, especially sponsor oversight activities in an outsourced model with vendors/CROs
  • Contribute to clinical study planning and selection of vendors/CRO partners
  • Contribute to study document development, writing and review (e.g. study protocol, IB, ICF…) including study specific plans and tracking tools
  • Contribute to competent authority and ethics committee submissions
  • Contract negotiations with clinical study sites and vendors/CRO partners
  • Perform co-monitoring visits as required
  • Contribute to the company Quality Management System (QMS) including writing of Standard Operating Procedures (SOPs)

Qualification profile

  • University degree in health profession or science or relevant hands-on experience
  • Extensive experience of managing clinical trial activities in the biopharmaceutical or CRO industry including clinical project management and on-site monitoring both preferably in oncology (approx. five years)
  • Deep understanding of cross functional drug development process and regulations (e.g. GCP, GCLP, ICH, AMG …), experience in SOP writing is a plus
  • Ability to handle high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
  • Self-motivated team player with a clear focus on execution
  • Strong communication and organizational skills with a pragmatic and problem-solving attitude
  • Fluent German and English written and spoken
  • Willingness to travel (limited travel activity)

Benefits

  • Contribute to a high-impact clinical project developed in a high unmet need orphan disease in oncology
  • Working in a multinational and interdisciplinary small team without hierarchy
  • Pleasant and flexible working environment in a young, dynamic and highly committed team including international partners from several countries
  • Personal and professional development through responsibilities across a broad range of subjects
  • Opportunity to work either part-time or full-time in a flexible manner (if applicable), home office possible

Send application to

Please send your CV and references including the desired salary and potential start date to careers@thermosome.com.
Thermosome GmbH ▪ Am Klopferspitz 19 ▪ 82152 Planegg/Martinsried ▪ Germany ▪ http://www.thermosome.com
Thermosome is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, or age.

While applying for the job please refer to jobvector and use the following reference number: CTM2019

About Thermosome GmbH

Thermosome is an entrepreneurial biopharmaceutical company located in Martinsried near Munich that strives to develop proprietary drug candidates in the field of oncology. Core of our development is our unique, proprietary and patent-protected drug delivery technology using a thermo-sensitive nanocarrier for local high-concentrated delivery of active pharmaceutical ingredients (APIs). Our...
More about Thermosome GmbH